Lybrel

INDICATIONS

LYBREL (levonorgestrel and ethinyl estradol tablets) is indicated for the prevention of pregnancy in women who elect to use
oral contraceptives as a method of contraception.

Oral contraceptives are highly effective for pregnancy prevention. Table 2
lists the typical unintended pregnancy rates for users of combination oral contraceptives
and other methods of contraception. The efficacy of these contraceptive methods,
except sterilization, the IUD, and implants, depend upon the reliability with
which they are used. Correct and consistent use of methods can result in lower
failure rates.

Table 2: Percentage of Women Experiencing an Unintended Pregnancy
During The First Year of Typical Use and The First Year of Perfect Use of Contraception
and The Percentage Continuing Use at The End of the First Year. United States.

% of Women Experiencing an Unintended Pregnancy
within the First Year of Use

% of Women Continuing Use at One Year 3

Method (1)

Typical Use 1 (2)

Perfect Use 2 (3)

(4)

Chance 4

85

85

Spermicides 5

26

6

40

Periodic abstinence

25

63

Calendar

9

Ovulation Method

3

Sympto-Thermal 6

2

Post-Ovulation

1

Cap 7

Parous Women

40

26

42

Nulliparous Women

20

9

56

Sponge

Parous Women

40

20

42

Nulliparous Women

20

9

56

Diaphragm 7

20

6

56

Withdrawal

19

4

Condom 8

Female (Reality™)

21

5

56

Male

14

3

61

Pill

5

71

Progestin only

0.5

Combined

0.1

IUD

Progesterone T

2.0

1.5

81

Copper T380A

0.8

0.6

78

LNg 20

0.1

0.1

81

Depo-Provera®

0.3

0.3

70

Levonorgestrel

Implants (Norplant®)

0.05

0.05

88

Female Sterilization

0.5

0.5

100

Male Sterilization

0.15

0.10

100

Emergency Contraceptive Pills: The FDA has
concluded that certain combined oral contraceptives containing ethinyl
estradiol and norgestrel or levonorgestrel are safe and effective for
use as postcoital emergency contraception. Treatment initiated within
72 hours after unprotected intercourse reduces the risk of pregnancy by
atleast 75%.9
Lactation Amenorrhea Method: LAM is a highly effective, temporary method
of contraception.10
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J,
Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology:
Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
1. Among typical couples who initiate use of a method (not necessarily
for the first time), the percentage who experience an accidental pregnancy
during the first year if they do not stop use for any other reason.
2. Among couples who initiate use of a method (not necessarily for the
first time) and who use it perfectly (both consistently and correctly),
the percentage who experience an accidental pregnancy during the first
year if they do not stop use for any other reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue
to use a method for one year.
4. The percents becoming pregnant in columns (2) and (3) are based on
data from populations where contraception is not used and from women who
cease using contraception in order to become pregnant. Among such populations,
about 89% become pregnant within one year. This estimate was lowered slightly
(to 85%) to represent the percent who would become pregnant within one
year among women now relying on reversible methods of contraception if
they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory
and basal body temperature in the post-ovulatory phases.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected
intercourse, and a second dose 12 hours after the first dose. The FDA
has declared the following dosage regimens of oral contraceptives to be
safe and effective for emergency contraception: for tablets containing
50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets;
for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel
1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol
and 150 mcg of levonorgestrel 1 dose is 4 tablets.
10. However, to maintain effective protection against pregnancy, another
method of contraception must be used as soon as menstruation resumes,
the frequency or duration of breastfeeds is reduced, bottle feeds are
introduced, or the baby reaches 6 months of age.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, LYBREL (levonorgestrel and ethinyl estradol tablets) (levonorgestrel and
ethinyl estradiol tablets) must be taken exactly as directed and at intervals
not exceeding 24 hours. The possibility of ovulation and conception prior to
initiation of medication should be considered. Women who do not wish to become
pregnant after discontinuation should be advised to immediately use another
method of birth control. The dosage of LYBREL (levonorgestrel and ethinyl estradol tablets) is one yellow tablet daily without
any tablet-free interval.

It is recommended that LYBREL (levonorgestrel and ethinyl estradol tablets) tablets be taken at the same time each
day.

Day 1 of patient's menstrual cycle (during the first 24 hours of her
period)

No

21-day COC regimen OR
28-day COC regimen

Day 1 of patient's withdrawal bleed, at the latest 7 days after her
last active tablet

No

Progestin-only pill

Day after taking a progestin-only pill

Yes, for the first 7 days of LYBREL tablet taking

Implant

Day of implant removal

Yes, for the first 7 days of LYBREL tablet taking

Injection

Day the next injection is due

Yes, for the first 7 days of LYBREL tablet taking

If spotting or unscheduled bleeding occurs, the patient is instructed to continue
on the same regimen. This type of bleeding is usually transient and without
significance; however, if the bleeding is persistent or prolonged, the patient
is advised to consult her health care professional. The possibility of ovulation
increases with each successive day that scheduled yellow tablets are missed.
If the patient has not adhered to the prescribed schedule (missed one or more
tablets or started taking them on a day later than she should have), the probability
of pregnancy should be considered. Hormonal contraception must be discontinued
if pregnancy is confirmed.

The risk of pregnancy increases with each tablet missed. For additional patient
instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS
section in the DETAILED PATIENT LABELING
section.

LYBREL (levonorgestrel and ethinyl estradol tablets) may be initiated no earlier than day 28 postpartum in the nonlactating
mother or after a second-trimester abortion due to the increased risk for thromboembolism
(see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning
thromboembolic disease). The patient should be advised to use a nonhormonal
back-up method for the first 7 days of tablet-taking. However, if intercourse
has already occurred, pregnancy should be excluded before the start of combined
oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first-trimester abortion, if the patient starts LYBREL (levonorgestrel and ethinyl estradol tablets) immediately,
additional contraceptive measures are not needed.